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Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network

Sponsor
Thomas Jefferson University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05627219
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training and Education
  • Other: Educational Intervention
  • Procedure: Discussion
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)
SECONDARY OBJECTIVE:
  1. Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.
OUTLINE:

AIM 1: Peer genetic coaches undergo training and education on study.

AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (training, education, discussion)

AIM 1: Peer genetic coaches undergo training and education on study. AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Behavioral: Training and Education
Undergo training and education

Other: Educational Intervention
Receive educational booklet
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention
  • Educational

    • Procedure: Discussion
    Attend discussion with peer genetic coach
    Other Names:
  • Discuss

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of inquiries to the central number (feasibility) [Up to 1 year]

    2. Percent of callers screened and eligible to participate (feasibility) [Up to 1 year]

    3. Percent of eligible callers who enroll in the study (feasibility) [Up to 1 year]

    4. Percent who complete the endpoint assessment (feasibility) [Up to 1 year]

    5. Number and percent of men making genetic counseling appointments [Up to 1 year]

    Secondary Outcome Measures

    1. Change in decisional conflict for genetic counseling [Baseline up to 1 year]

      Reported with mean and standard deviation.

    2. Change in acceptability/attitude toward genetic counseling and testing [Baseline up to 1 year]

      Reported with mean and standard deviation.

    3. Change of genetics knowledge [Baseline up to 1 year]

      Reported with mean and standard deviation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • AIM 1: Are 18 years old or older

    • AIM 1: Are able to read and speak English comfortably

    • AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience

    • AIM 2: Are 18 years old or older

    • AIM 2: Are African American

    • AIM 2: Are able to read and speak English comfortably

    • AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer

    Exclusion Criteria:

    • Patients that do not meet the inclusion criteria

    • Children under the age of 18

    • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT05627219
    Other Study ID Numbers:
    • 22C.423
    First Posted:
    Nov 25, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 15, 2022